MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 100MM; ROD, FIXATION

Model Number	8145-10-100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had affixus nail implanted.Subsequently, revision procedure was performed to remove the fractured nail and external fixation was put in place.
Additional Manufacturer Narrative
(b)(4).Event date: unknown day in (b)(6) 2021.Implant date: unknown day in (b)(6) 2020.Concomitant medical products: cat: 814509380 lot: 973540 hfn rh 130 deg 9mm x 380mm.Cat: unknown screw lot: unknown.Cat: unknown screw lot: unknown.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00851, 0001825034 - 2022 - 00849, and 0001825034 - 2022 - 00850.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.

• Brand Name: HFN LAG SCREW 10.5MM X 100MM
• Common Device Name: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14052085
• Report Number: 0001825034-2022-00848
• Device Sequence Number: 4923468
• Product Code: HSB
• UDI-Device Identifier: 00887868039027
• UDI-Public: (01)00887868039027
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8145-10-100
• Device Catalogue Number: 814510100
• Device Lot Number: WG1111300A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female